DC-90/DC-90S/DC-900/DC-95/DC-95S/DC-88/DC-80A/DC-80A Exp/DC-80A Pro/DC-80A Pro/DC-8X/DC-80/DC-80/DC-80/DC-80/DC-81/ DC-82 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatic, small organ(breast, thyroid, testes), neonatal and adult cephalic, transrectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediative cardiac, peripheral vessel and urology exams.

Device Description

DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, PW-mode, CW mode, Color-mode, Color M-mode, Power/Dirpower mode, TDI mode, THI, iScape, Biopsy Guidance, 3D/4D mode, Elastography, Contrast imaging or the combined mode (i.e. B/M-Mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array.

AI/ML Overview

The provided text describes the regulatory clearance for the DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System. However, it does not contain specific acceptance criteria, detailed study results, or performance metrics for an AI model.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical specifications, intended uses, and compliance with various safety and performance standards for an ultrasound system, not an AI component. It states "Clinical Tests: Not Applicable." indicating that a clinical study to prove the device meets acceptance criteria via performance metrics for an AI system was not performed or deemed necessary for this 510(k) submission.

Therefore, I cannot populate the requested tables and information based on the provided text, as the information is not present. The document is about the FDA clearance of an ultrasound system, not an AI software/device that would typically have specific performance acceptance criteria demonstrated through a clinical study with detailed results, ground truth, and expert evaluation.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 8, 2019 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Zhang Wei Engineer of Technical Regulation Keji 12th Road South, Hi-tech Industrial Park Shenzhen, Guangdong 518057 CHINA Re: K190206 Trade/Device Name: DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/ DC-80A/DC/80A Exp/DC-80A Pro/DC-8X/DC-80/DC-81/DC82 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX, LLZ Dated: January 25, 2019 Received: February 4, 2019

Dear Zhang Wei:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jeff Rogge

for Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K190206

Device Name

DC-90/DC-90S/DC-900/DC-95/DC-95/DC-88/DC-888/DC-80A/DC-80A Pro/DC-80A Pro/DC-80/DC-80/DC-81/DC-81/DC-81 Diagnostic Ultrasound System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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System:	DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC- 8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System
Transducer:	N/A
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application			Mode of Operation
General (Track1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal	N	N	N		N	N	N	Note 1, 2,3, 4, 6, 7
	Abdominal	N	N	N	N	N	N	N	Note 1, 2,3,4,6,7,9,11,12
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	Small Organ (Specify**)	N	N	N	N	N	N	N	Note 1,2, 4,7,8,11,12
	Neonatal Cephalic	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	Adult Cephalic	N	N	N	N	N	N	N	Note 1,2,4,6,7
	Trans-rectal	N	N	N	N	N	N	N	Note 1, 2,3, 4, 6, 7, 8
	Trans-vaginal	N	N	N	N	N	N	N	Note 1, 2,3, 4, 6, 7, 8
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	Note 1, 2,4,6,7,8,11,12
	Musculo-skeletal(Superficial)	N	N	N		N	N	N	Note 1, 2, 4,7,8,11,12
	Intravascular
	Cardiac Adult	N	N	N	N	N	N	N	Note 1, 2,4,5,6,7,10
	Cardiac Pediatric	N	N	N	N	N	N	N	Note 1, 2, 4,5,6,7
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	N	N	N		N	N	N	Note 1, 2, 4,6,7
	Other (Specify***)	N	N	N		N	N	N	Note 1, 2, 4, 6, 7,8
	N=new indication; P=previously cleared by FDA;					E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power+PW+B.
	*Intraoperative includes abdominal, thoracic, and vascular
	** Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note 8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging(contrast agent for LVO)
	Note 11: STENote 12: STQ
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Prescription USE (Per 21 CFR 801.109)

System:	DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-
8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System
Transducer:	C11-3E
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical ApplicationMode of Operation
General (Track1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
	Ophthalmic
	Fetal
	Abdominal	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	Small Organ (Specify**)
	Neonatal Cephalic	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
Cardiac	Intravascular (Cardiac)Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vesselOther (Specify***)	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	N=new indication; P=previously cleared by FDA; E=added under Appendix EAdditional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power+PW+B.
	Intraoperative includes abdominal, thoracic, and vascular etc.*Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note 8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging(contrast agent for LVO)
	Note 11: STE
	Note 12: STQ
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Prescription USE (Per 21 CFR 801.109)
System:	DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System
Transducer:	L12-3E
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application		Mode of Operation
General (Track1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	N	N	N		N	N	N	Note 1, 2, 4,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1, 2, 4,7
	Small Organ (Specify**)	N	N	N		N	N	N	Note 1,2, 4,7,8,11,12
	Neonatal Cephalic
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	Note 1, 2, 4,7,11,12
	Musculo-skeletal(Superficial)	N	N	N		N	N	N	Note 1, 2, 4,7,11,12
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	N	N	N		N	N	N	Note 1, 2, 4,7
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power+PW+B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note 8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging(contrast agent for LVO)
	Note 11: STE
	Note 12: STQ
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Prescription USE (Per 21 CFR 801.109)

System:	DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System
Transducer:	P7-3E
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application
		Mode of Operation
General (Track1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	N	N	N	N	N	N	N	Note 1,2,4,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1,2,4,6
	Small Organ (Specify**)
	Neonatal Cephalic	N	N	N	N	N	N	N	Note 1,2,4,6
Fetal Imaging& Other	Adult Cephalic	N	N	N	N	N	N	N	Note 1,2,4,6
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Cardiac Adult	N	N	N	N	N	N	N	Note 1, 2,4,5,6
	Cardiac Pediatric	N	N	N	N	N	N	N	Note 1, 2,4,5,6
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M\u3001PW+B\u3001Color + B\u3001Power+B\u3001PW+Color+B\u3001Power+PW+B.*Intraoperative includes abdominal, thoracic, and vascular etc.
	Small organ-breast, thyroid, testes.*Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)Note 4: iScape
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note 8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging(contrast agent for LVO)
	Note 11: STE
	Note 12: STQ
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Prescription USE (Per 21 CFR 801.109)

System:	DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC- 8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System
Transducer:	L9-3E
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
General (Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	N	N	N		N	N	N	Note 1,2, 4,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1,2, 4,7
	Small Organ (Specify**)	N	N	N		N	N	N	Note 1,2, 4,7,8,11,12
	Neonatal Cephalic
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	Note 1,2, 4,7,11,12
	Musculo-skeletal(Superficial)	N	N	N		N	N	N	Note 1,2, 4,7,11,12
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	N	N	N		N	N	N	Note 1,2, 4,7
	Other (Specify***)
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power+PW+B.
*Intraoperative includes abdominal, thoracic, and vascular
**Small organ-breast, thyroid, testes,
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note 5: TDI
Note 6: Color M
Note 7: Biopsy Guidance
Note 8: Elastography
Note 9: Contrast imaging (Contrast agent for Liver)
Note 10: Contrast imaging(contrast agent for LVO)
Note 11: STE
Note 12: STQ
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription USE (Per 21 CFR 801.109)
System:	DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC- 8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System
Transducer:	DE11-3E
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	General (Track 1 Only)	Specific (Track 1 & 3)	Mode of Operation						Other (Specify)
			B	M	PWD	CWD	Color Doppler	Amplitude Doppler		Combined (specify)
	Ophthalmic	Ophthalmic
Fetal Imaging & Other		Fetal	N	N	N	N	N	N	N	Note 1, 3, 4, 6, 7
		Abdominal
		Intra-operative (Specify*)
		Intra-operative (Neuro)
		Laparoscopic
		Pediatric
		Small Organ (Specify**)
		Neonatal CephalicAdult Cephalic
		Trans-rectal	N	N	N	N	N	N	N	Note 1, 3, 4, 6, 7, 8
		Trans-vaginal	N	N	N	N	N	N	N	Note 1, 3, 4, 6, 7, 8
		Trans-urethral
Cardiac		Trans-esoph. (non-Card.)
		Musculo-skeletal (Conventional)
		Musculo-skeletal (Superficial)
		Intravascular
		Cardiac Adult
		Cardiac Pediatric
		Intravascular (Cardiac)
		Trans-esoph. (Cardiac)
		Intra-cardiac

Peripheral vessel		Peripheral vessel
		Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix EAdditional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power+PW+B.Intraoperative includes abdominal, thoracic, and vascular.Small organ-breast, thyroid, testes.**Other use includes Urology.Note 1: Tissue Harmonic Imaging.Note 2: Smart3DNote 3:4D(Real-time 3D)Note 4: iScapeNote 5: TDINote 6: Color MNote 7: Biopsy GuidanceNote 8: ElastographyNote 9: Contrast imaging (Contrast agent for Liver)Note 10: Contrast imaging(contrast agent for LVO)Note 11: STENote 12: STQ(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
System:	DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System
Transducer:	V11-3HE
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application						Mode of Operation
General (Track1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (Specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N	N	Note 1, 2, 4, 6, 7
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal	N	N	N		N	N	N	Note 1, 2, 4, 6, 7, 8
	Trans-vaginal	N	N	N		N	N	N	Note 1, 2, 4, 6, 7, 8
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)	N	N	N		N	N	N	Note 1, 2, 4, 6, 7, 8
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power+PW+B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note 8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging(contrast agent for LVO)
	Note 11: STE
	Note 12: STQ
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Prescription USE (Per 21 CFR 801.109)
System:	DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System
Transducer:	SP5-1E
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
General (Track1 Only)	Clinical ApplicationSpecific (Track 1 & 3)	Mode of Operation
		B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal	N	N	N	N	N	N	N	Note 1, 2,4, 6,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1, 2,4, 6,7
	Small Organ (Specify**)
	Neonatal CephalicAdult Cephalic	N	N	N	N	N	N	N	Note 1, 2,4, 6,7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
Cardiac	Cardiac Adult	N	N	N	N	N	N	N	Note 1, 2,4,5,6,7,10
	Cardiac Pediatric	N	N	N	N	N	N	N	Note 1, 2,4,5,6,7
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power+PW+B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
		Note 6: Color M
		Note 7: Biopsy Guidance
		Note 8: Elastography
		Note 9: Contrast imaging (Contrast agent for Liver)
		Note 10: Contrast imaging(contrast agent for LVO)
		Note 11: STE
	Note 12: STQ
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Prescription USE (Per 21 CFR 801.109)
System:	DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC- 8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System
Transducer:	SC6-1E
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (Specify)
General (Track1 Only)	Specific (Track 1 & 3)
Ophthalmic	Ophthalmic
	Fetal	N	N	N	N	N	N	N	Note 1, 2, 4, 6,7
	Abdominal	N	N	N	N	N	N	N	Note 1, 2,4,6,7,9,11,12
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
Fetal Imaging& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	Musculo-skeletal(Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac

Peripheralvessel	Peripheral vessel	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power+PW+B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note 8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging(contrast agent for LVO)
	Note 11: STE
	Note 12: STQ
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Prescription USE (Per 21 CFR 801.109)
System:	DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC- 8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System
Transducer:	SD8-1E
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application						Mode of Operation
General (Track1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (Specify)
	Ophthalmic
	Fetal	N	N	N	N	N	N	N	Note 1, 3, 4, 6,7
	Abdominal	N	N	N	N	N	N	N	Note 1, 3, 4,6,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power+PW+B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
Note 6: Color M
Note 7: Biopsy Guidance
	Note 8: Elastography
Note9: Contrast imaging (Contrast agent for Liver)
Note 10: Contrast imaging(contrast agent for LVO)
	Note 11: STE
	Note 12: STQ
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Prescription USE (Per 21 CFR 801.109)
System:	DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-
	8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System
Transducer:	L14-5WE
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application						Mode of Operation
General (Track1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	N	N	N		N	N	N	Note 1,2, 4,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1,2, 4,7
	Small Organ (Specify**)	N	N	N		N	N	N	Note 1,2, 4,7,8,11,12
	Neonatal Cephalic	N	N	N		N	N	N	Note 1,2, 4,7
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	Note 1,2, 4,7,11,12
	Musculo-skeletal(Superficial)	N	N	N		N	N	N	Note 1,2, 4,7,11,12
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac

Peripheralvessel	Peripheral vessel	N	N	N		N	N	N	Note 1,2, 4,7
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power+PW+B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note 8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	Note 11: STE
	Note 12: STQ
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Prescription USE (Per 21 CFR 801.109)
System:	DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System
Transducer:	L20-5E
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
General (Track1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)	N	N	N		N	N	N	Note 1, 2, 4
	Neonatal Cephalic
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	Note 1, 2, 4, 8
	Musculo-skeletal(Superficial)	N	N	N		N	N	N	Note 1. 2. 4. 8
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Peripheral vessel	N	N	N		N	N	N	Note 1, 2, 4
	Other (Specify***)
Peripheralvessel	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power+PW+B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note 5: TDI
Note 6: Color M
Note 7: Biopsy Guidance
Note 8: Elastography
Note 9: Contrast imaging (Contrast agent for Liver)
Note 10: Contrast imaging (Contrast agent for LVO)
Note 11: STE
Note 12: STQ
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription USE (Per 21 CFR 801.109)
System:	DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-
	8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System
Transducer:	SC5-1NE
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application			Mode of Operation
General (Track						Color		Amplitude Combined
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Doppler	Doppler	(specify)	Other (Specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N	N	Note 1, 2, 4, 6,7
	Abdominal	N	N	N		N	N	N	Note 1, 2, 4,6,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
Fetal Imaging	Adult Cephalic
& Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
	(Conventional)	N	N	N		N	N	N	Note 1, 2, 4,6,7
	Musculo-skeletal
	(Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel	N	N	N		N	N	N	Note 1, 2, 4,6,7
vessel	Other (Specify***)
	N=new indication; P=previously cleared by FDA;					E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power+PW+B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	** Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
Note 2: Smart3D
	Note 3:4D(Real-time 3D)
Note 4: iScape
Note 5: TDI
Note 6: Color M
Note 7: Biopsy Guidance
Note 8: Elastography
Note 9: Contrast imaging (Contrast agent for Liver)
Note 10: Contrast imaging(contrast agent for LVO)
Note 11: STE
Note 12: STQ
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Prescription USE (Per 21 CFR 801.109)

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510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

1. Submitter:

Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Tel: +86 755 8188 5655 Fax: +86 755 2658 2680

Contact Person:

Zhang Wei

Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Date Prepared: January 25, 2019

2. Device Name:

DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System Classification Regulatory Class: II Review Category: Tier II 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (IYN) 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (IYO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX) 21 CFR 892.2050 Picture Archiving and Communications System(LLZ)

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3. Device Description:

DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A

Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, PW-mode, CW mode, Color-mode, Color M-mode, Power/Dirpower mode, TDI mode, THI, iScape, Biopsy Guidance, 3D/4D mode, Elastography, Contrast imaging or the combined mode (i.e. B/M-Mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array.

4. Intended Use:

The DC-80A /DC-80A Exp/DC-80A DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-95S/DC-88/DC-88S/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel and urology exams.

5. Comparison with Predicate Devices:

DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

Predicate Device	Manufacturer	Model	510(k) Control Number
1. Primary predicate device	Mindray	DC-70	K181637
2. Reference device	Mindray	Resona 7	K171233

DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-888/DC-80A/DC-80A

Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System employs the same technology as the predicate devices. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate onscreen display of

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anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations. The subject device also has the same intended uses and basic operating modes as the predicate devices.

Subject device DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 has the similar intended uses with the predicated device DC-70(K181637) .
The materials of probes and Needle-guided brackets of . DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-95S/DC-88/DC-88S/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 are the same to the predicate device DC-70(K181637).
. The acoustic power levels of DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 are below the limits of FDA, which is the same as the predicated device DC-70(K181637).
DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device DC-70(K181637).

PredicateDevice	Model	Items	Specific differences
1. Primarypredicatedevice	DC-70	Differences ofIntended uses	The DC-70 series have more intendeduses about Trans-esoph. (Cardiac) andintra-operative (abdominal, thoracic, andvascular).But the DC-90 series don't have.
		Differences ofTransducers	The DC-90 series support one newtransducer which is SC5-1NE.The other transducers that SC6-1E,C11-3E, L12-3E, L9-3E, V11-3HE,SP5-1E, P7-3E, SD8-1E, L14-5WE,L20-5E, DE11-3E were cleared by

The differences between the DC-90 series and the predicate devices:

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			DC-70.
		Hardwareplatformimprovement	One more transducer port of DC-90series.
			The battery of DC-90 series can providepower supply when working.
			The DC-90 series have two hard disks(128G SSD+1T HDD) and the DC-70series only have one hard disk (1T HDD).
			The signal channel between the probe andthe main host is 128. The DC-70 seriesonly have 64.

		Differences ofSoftwareFunctions	The DC-90 series have new SoftwareFunctions: STE, STQ, Smart Pelvic andDehaze;

2. Referencedevice	Resona7	New SoftwareFunctions	The Software Functions about STE, STQ,Smart Pelvic were cleared in Resona 7(K171233)

6. Non-clinical Tests:

DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A

Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System has been evaluated for software, cybersecurity testing, acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards.

Non-clinical tests relied on in this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards:

AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and ■ a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod).
. IEC 60601-1-2 Edition 4.0 2014-02, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
. IEC 60601-2-37 Edition 2.1 2015, medical electrical equipment - part 2-37:

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particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.

IEC 62304 Edition 1.1 2015-06, medical device software software life cycle . processes.
. ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices.
NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic . ultrasound equipment revision 3.
AAMI / ANSI / ISO 10993-1:2009/(R)2013, biological evaluation of medical . devices - part 1: evaluation and testing within a risk management process.
. IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]
. IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

7. Clinical Tests:

Not Applicable.

8. Conclusion:

Intended uses and other key features are consistent with traditional clinical practices. FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the

DC-90/DC-90S/DC-900/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.